System and method for treatment of anal incontinence and pelvic organ prolapse

ABSTRACT

Using a sling that includes a central portion and at least two arms extending from the central portion, a method of treating anal incontinence may include positioning the central portion posteriorly to the rectum and/or anus of a subject, and extending each arm of the sling to a respective obturator region. Using a sling having the same or similar structure, a method of treating pelvic organ prolapse may include positioning the central portion beneath the ano-rectum of a subject, and extending each arm of the sling to a respective thigh incision near the obturator region.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a continuation of U.S. patentapplication Ser. No. 11/765,761, filed Jun. 20, 2007, which is acontinuation-in-part of PCT Application No. PCT/US05/46201, filed Dec.20, 2005, which claims the benefit of U.S. Provisional Application No.60/637,665, filed Dec. 20, 2004 and also claims the benefit of U.S.Provisional Application No. 60/673,878, filed Apr. 22, 2005, theentireties of which are hereby incorporated by reference. Thisapplication also claims the benefit of U.S. Provisional Application No.60/868,850, filed Dec. 6, 2006, the entirety of which is herebyincorporated by reference.

BACKGROUND OF THE INVENTION

Anal incontinence is a common problem that occurs in both men and women,though is certainly more prevalent in women after vaginal childbirth,presumably the result of trauma to pelvic floor muscles, supportingfascia and nerves. Fecal incontinence affects an estimated 7.6 percentof women between the ages of 30-90. The prevalence increases with age,affecting 3.6 percent of women between 30-39 and 15.2 percent of womenbetween 80-90. Several factors contribute to anal continence, includingthe resting tone of the external and internal anal sphincters, as wellas the position of the levator ani muscles, especially the puborectalismuscle, which forms a sling around the rectum and is responsible for theso-called “ano-rectal angle,” which keeps stool in the rectum untilvoluntary defecation relaxes the puborectalis muscle and straightens theangle, allowing stool to move towards the anus.

Defecation is often aided by expulsive abdominal forces. Analincontinence may occur as the result of several mechanisms, includingdirect damage to the internal or external anal sphincters (fromiatrogenic episiotomy or spontaneous lacerations during vaginaldelivery), or to the levator ani muscles. It may also result fromindirect injury of these muscles through denervation of the nerves thatsupply these muscles. Treatment of this problem has centered on pelvicfloor rehabilitation, dietary changes, or surgical correction. Surgeryhas been used to treat specific defects in the anal sphincters, such asexternal anal sphincteroplasty. Success rates of only 50% or less aregenerally reported for these procedures on long-term follow-up.

More recently, an artificial anal sphincter has been used to bypassthese muscles, though this surgery involves fairly extensive dissectionand requires the patient to depress a subcutaneous valve whichtemporarily deflates the sphincter cuff and allows voluntary defecation.This procedure is performed in very few centers in the U.S., and even inexperienced hands, complications occur frequently. Dynamicgraciloplasty, which involves mobilization and wrapping of the gracilismuscle around the anorectum is now another accepted procedure althoughis remains complex and requires extensive experience to obtain goodresults. More recently, sacral nerve stimulation has been used with somesuccess to treat fecal incontinence, though the mechanism of success inthese patients remains unclear, and may not be appropriate in women withobvious anatomic abnormalities, such as anal sphincter or levator muscledisruptions.

In addition, many women report other symptoms of bowel dysfunction, suchas constipation and incomplete bowel emptying. For some women, thesesymptoms are due to either an anterior rectocele (a hernia of the rectuminto the vaginal canal), or due to a defect in the levator ani muscles,which results in descent of the levator plate and/or perineum withabdominal straining In addition, patients may be noted to have a defectin the posterior aspect of the rectum, or a posterior rectocele. Thereare very few treatment options for this condition, though retrorectallevatorplasty has been used in the past. In this procedure, an incisionis made between the anus and the coccyx and the levator muscles areexposed bilaterally. Sutures are then placed in the levator muscles toplicate them together in the midline.

Pelvic organ prolapse is a condition where organs, such as the uterus,the rectum, or the bladder, fall down or slip out of place within aperson's body. It is commonly used in reference to organs protrudingthrough a woman's vagina, but prolapse may occur within men as well. Ingeneral, the levator ani muscles provide the main support for pelvicorgans including, for example, the rectum, the vagina, and the urethra.In a person with a normal pelvis, the levator ani muscles keep thepelvic floor closed, thereby allowing the pelvic and abdominal organs torest on the levator ani muscles. This also significantly reduces thetension that would otherwise be placed on the fascia and ligaments thatsupport the pelvic organs. The posterior portion of the levator animuscles arise from the area of the tendinous arch. The anterior portionof the levator ani muscles arise from the superior pubic rami and fromthe anterior end of the obturator internus muscles. This portion formsthe pubococcygeus muscle and the puborectalis muscle. The pubococcygeusmuscle is a generally thick, U-shaped muscle through which the urethra,vagina, and rectum transverse. The pubococcygeus muscle supports thesestructures at rest, and helps to augment the endopelvic fascia duringcoughing or straining The puborectalis muscle is structured to act as asling support for the rectum, and includes two ends that attach to theanterior side of the symphysis pubis. The levator ani muscle groupincludes an opening through which the vagina and urethra pass, which isreferred to as the urogenital hiatus. Similarly, the levator ani musclegroup includes an opening through which the rectum passes, which isreferred to as the rectal hiatus.

In a normal woman, the pelvic floor muscles support most of the weightof the pelvic organs, such as the vagina, uterus, bladder, and rectum.Additionally, the various pelvic fascia and ligaments stabilize thesestructures in position. When the normal anatomic relationships in thepelvis are disrupted, or if injuries occur, dysfunctions such as urinaryincontinence, fecal incontinence, or prolapse of the pelvic organs, mayoccur. For example, if one of the levator ani muscles is damaged, themuscle may be unable to adequately support the weight of the pelvicorgans. This will result in a disproportionate amount of the pelvicorgan weight being placed onto the pelvic ligaments, which aresignificantly weaker than the fibrous tissue of the ligaments thatconnect bones. In particular, the pelvic ligaments are more accuratelydescribed as thickening of the endopelvic fascia tissue, which iscomposed of collagen, smooth muscle, elastin, and fibrovascular bundles.These ligaments are not designed to carry the increased load resultingfrom problems in the pelvic floor. As a result, these ligaments mayeventually fail. The failure or damage to the pelvic floor ligaments maycause, for example, the bladder, rectum, or uterus to prolapse throughthe vagina. Similarly, expansion of or damage to the levator or rectalhiatus may result in the bladder, vagina, or rectum prolapsing throughthe hiatus.

As stated previously, pelvic prolapse conditions result from theweakness or damage to the normal pelvic-support systems. In general, themain categories of pelvic prolapse include cystocele, rectocele,enterocele, uterine prolapse, and vaginal vault prolapse. The mostcommon causes of these pelvic floor disorders in a female patientinclude child birth and removal of the uterus (hysterectomy). However,other contributing factors may include connective tissue defects,prolonged heavy physical labor, postmenopausal atrophy, neurogenicweakness of muscles, muscle weakness due to aging, and obesity.

A cystocele occurs when damage to the pubocervical fascia in the centralor lateral areas (or both) allows the bladder to protrude into thevagina. Simply defined, a cystocele is a protrusion of the bladder intothe vagina due to defects in pelvic support.

A rectocele is a bulge into the vagina caused by the rectum prolapsingthrough an attenuated rectovaginal septum. A rectocele is commonly aresult of childbirth or chronic constipation. During childbirth, therectovaginal septum and surrounding vaginal tissues are stretched anddisrupted, which may cause weakness and stretching in these tissues. Arectocele typically forms a pocket just above the anal sphincter wherestool may become trapped.

An enterocele is essentially a herniation of the small bowel into thevagina. Specifically, the peritoneal sac containing a portion of thesmall bowel extends into the rectovaginal space between the posteriorsurface of the vagina and the anterior surface of the rectum.

A uterine prolapse is the distention of the uterus and cervix outsidethe vagina. It is often associated with a rectocele, cystocele, orentrocele.

Finally, a vaginal vault prolapse is the distention of the vaginal apexafter hysterectomy outside the vagina. It is also often associated witha rectocele, cystocele, or entrocele.

BRIEF SUMMARY OF THE INVENTION

The present disclosure describes systems and methods for treating analincontinence, and other types of defecatory dysfunction, such asperineal descent, constipation, incomplete bowel emptying, and rectalprolapse. The present disclosure also describes systems and methods fortreating pelvic organ prolapse and other pelvic floor disorders. Somedisclosed systems and methods particularly facilitate minimally-invasivetreatment of anal incontinence and pelvic organ prolapse.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the anatomy of the bony pelvis.

FIG. 2 depicts an exemplary placement of a device in the pelvis.

FIGS. 3-4 depict steps in one exemplary placement method.

FIGS. 5-6 depict steps in another exemplary placement method.

FIG. 7 depicts an exemplary final position of a length of supportingmaterial.

FIGS. 8-10 depict exemplary uses of two lengths of supporting material.

FIGS. 11-19 depict exemplary uses of various instruments to position alength of supporting material.

FIGS. 20-22 depict exemplary slings.

FIGS. 23-25 depict exemplary slings having fluid-filled sacs.

FIGS. 26-29 depict an exemplary use of a stylet having a loop.

FIGS. 30-31 depict an exemplary use of a stylet having a hook.

FIGS. 32-38 depict additional exemplary embodiments of slings.

FIG. 39 depicts use of an exemplary device to measure the ano-rectalangle.

FIGS. 40-41 depict placement of a sling having a saddle-shaped centralportion.

FIG. 42 generally depicts one exemplary method for treating pelvic organprolapse according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure provides a variety of systems and methods fortreating anal incontinence. The normal ano-rectal angle can be restoredby inserting a disclosed device under the posterior rectum, which may besupported with a synthetic or natural material in a sling-like positionbehind the anus and/or rectum. A posterior supporting apparatus mayprovide partial or complete closure of the rectum and/or anus with theposterior supporting apparatus.

In one embodiment, a synthetic or natural sling material may be placedunder the rectum and may be supported by its arms, which may be extendedup in a sling-like fashion through the obturator foramen bilaterally, orretropubically to the suprapubic region. In another embodiment, thedevice placed posterior to the rectum may include an inflatable orfluid-filled sac, which may or may not be adjusted post-operatively, byeither changing its position or by altering the amount of fluidmaterial, for example saline or a hydrogel, within the sac. “Fluid” isunderstood to include gasses, liquids, and semisolid media (such asgels). In some embodiments, the central portion of the sling may have acurved shape, such as a saddle shape, to help it conform to the externalcontour of the anus, rectum, ano-rectal angle, and/or levator animuscles.

In one embodiment of a method of treating anal incontinence, an incisionmay be made between the anus and the coccyx and dissection performed,whereby the levator muscles and the levator plate are exposed. A smallnick may be made on the medial thigh just lateral to the ischiopubicramus and an introducer needle may be placed through the medial thighincision, around the ischiopubic ramus, and be directed posteriorly intothe ischiorectal fossa. The needle may then be directed lateral to thelevator muscles, optionally with the assistance of a surgeon palpatingthe instrument though the vagina. The needle may then be broughtposterior to the rectum, exiting the incision that was made in themidline. Alternatively, the needle may be passed from the midlineincision between the anus and coccyx to the medial thigh incisionlateral to the ischiopubic ramis. In one embodiment, a suture may bethreaded onto the eye of the needle, which in this case may be placedfrom the medial thigh to the incision between the anus and the coccyx,and may then be withdrawn through the tissue and held on the medialthigh. The procedure is repeated on the contralateral side. A synthetic(i.e., polypropylene, polyester, etc.) mesh (such as tension-freevaginal tape, TVT) or natural graft material may then be attached toeach of the sutures coming from the midline incision, and the mesh maythen be brought up through the medial thigh incisions by pulling up onthe sutures.

The mesh may have a covering plastic sheath, which can facilitatepassage through the tissues. The sheath may be removed when the sling isproperly adjusted.

In another embodiment, the needle that is passed through the tissue mayhave a hollow sleeve or tube over it (e.g., made of plastic, metal, orthe like), and after passage, the needle may be withdrawn through thetissue, leaving the hollow sleeve in place. A stylet (e.g., made ofplastic, metal, or the like) may then be then placed in the tube. Thestylet may have a connector, such as a hook or a loop, so that a lengthof supporting material, such as a synthetic mesh (e.g., made ofpolypropylene or the like) or a natural graft, may be attached to thestylet connector. Exemplary uses of stylets with hooks or loops areshown in FIGS. 26-31. Once this procedure is performed bilaterally, thesupporting material may be positioned under the rectum and the tensionon the arms of the sling are adjusted. If the sleeves or tubes areutilized, the mesh can be adjusted before withdrawing the sleeves ortubes.

In another embodiment, two passes of the needles can be made on eachside, one approximately at the level of the medial superior portion ofthe obturator foramen, and the other several centimeters inferior andslightly more lateral (at the inferior portion of the obturatorforamen). This permits two lengths of supporting material (also called“mesh” but not necessarily limited to mesh) to be brought up on eachside. These mesh strips are attached to a central mesh that may beplaced under the rectum, which may be a pre-formed mesh, or may beconstructed by attaching the central mesh to the four mesh strips—two oneach side. The subrectal portion may be synthetic mesh, or may be madeof another material, such as an inflatable or fluid-filled polymer sac.The sub-rectal element provides support to the posterior anus and/orrectum, and creates an angle between the anus and rectum, which keepsstool in the rectum until voluntary defecation.

In another embodiment, after the needle passes through the tissue, andis withdrawn, leaving a hollow tube in place, a plastic or metal stylet,previously fixed to the mesh with or without a sheath, can be placed upfrom the sub-rectal incision to the medial thigh incision and can beheld. The mesh may then be brought up through the tubing by pulling onthe stylet from above. Once the sling end comes out from the tubing, thehollow tube can be removed, after the sling has been adjusted for propertensioning.

In another embodiment, the posterior aspect of the sub-rectal portionmay be attached to the coccyx by one of several methods, such as directsuturing or with bone anchors. Such attachment can help maintain theposition of the sub-rectal portion, which, in effect, restores thestructure and function of the levator plate. Alternatively, thesub-rectal portion may have an extension coming off its inferiorportion, which extends out and is fixed to the coccyx.

The fluid-filled sac under or adjacent to the rectum may have a port,such as a subcutaneous port, that may allow for fluid addition orremoval in the post-operative period. This port may facilitatepost-operative adjustment of the size and/or shape of the sac to providefor optimal results. The subcutaneous port may be placed directly underthe sac, in the perineal skin, or may be connected to the sac by meansof a connector tubing so that the port does not need to be located inthe perineum itself, but instead may be positioned in a number of areas,including, for example, the buttocks.

The needle may have a hook near the end, that can be covered duringinsertion, but that may be exposed after the needle has been placedthrough the tissue. The user implanting the device may operate a switchor other actuator, such as a spring-loaded mechanism, to expose thehook. The arm of the sling, or a pre-loaded suture on the sling-arm, maythen be placed on the hook and the needle withdrawn through the tissue.

In another embodiment, once the needle is placed through the tissue, thetip of the needle may be unscrewed off the end of the needle shaft. Thearms of the sling may have a device attached to each end that may screwonto the needle shaft or otherwise fasten onto the needle shaft and thenthe needle is withdrawn, bringing the sling arm through the tissue.

A sheath covering the needle may remain in place in order to facilitatethe movement of the synthetic material through the tissue, which is onlyremoved once the tension on the sling is adjusted. The sheath may bedeformable, rather than rigid or semi-rigid, and may be flattened afterremoval of the needle, to accommodate the flat shape of the slingmaterial itself.

The needle could have blunt metallic insert (to maintain the strength ofthe needle) with a plastic covering sheath that has a sharp needle tipconfiguration on the end. After the needle is placed through the tissue,the metallic blunt needle is withdrawn, and the plastic needle tip cutoff. A suture retriever is then placed anterograde through the hollowplastic tube and grasps a suture that has been attached or pre-attachedto the sling. The sling is withdrawn through the plastic tube and thetube is removed once the sling is adjusted.

In another embodiment, the needle tip may be made from two separatepieces that act as jaws that open to catch the mesh or suture attachedto the mesh, after the needle is passed through the tissue from themedial thigh to the incision posterior to the anus. This needle may beintroduced with a plastic outer covering, so that the sling material maybe drawn up through the tissue without catching on the surroundingstructures. Once in proper position, the surgeon may remove the plasticsheath, which would then allow for the synthetic mesh to become fixed inthe tissues.

A curved metal needle may be placed through the tissue from the medialthigh to the perineal incision. The end of the needle may be unscrewed,and the sling with attached plastic or metal piece may be screwed orsnapped onto or into the connector on the needle. The sling, possiblywith covering sheath, may then be withdrawn through the tissue and heldand the plastic sheath is removed after the sling has been adjusted.

The shape of the sling may be a fixed width throughout its length.Alternatively, the central portion that is positioned under/behind therectum may be wider than the arms. The central portion may be curved tohelp it conform to the shape of the tissue it is supporting. The curvedshape may be a saddle shape, such as roughly a hyperbolic paraboloid orresembling a PRINGLES® brand potato crisp. The central portion may bepreformed with the curved shape.

The mesh may be continuous throughout the length of the sling, or mayhave a central portion that includes a fluid-filled sac that is affixedto the sling anns on the sides. Preferably, the synthetic mesh would becontinuous throughout its length in order to provide a backboard ofsupport under the rectum and under the fluid-filled sac, if thefluid-filled sac is employed.

The fluid sac may have a circular or elongated shape under the rectum,or may include several compartments that can be separately filled withseveral access ports, in order to change the occlusion of the rectum.The fluid filled sac may have the curved shapes as discussed above.

Wings may connect a sling central portion to the arms of the sling. Thewings may be made of mesh or other supporting material.

In another embodiment, the sling may be a hybrid of materials, comprisedof, for instance, a polypropylene mesh along the arms of the sling inorder to have self-attaching properties to the obturator fascia, and anatural xenograft material, such as porcine small intestinal submucosa,or an allograft, such as cadaveric fascia, located under and or lateralto the anus/rectum.

In another embodiment, the arms of the sling may include a syntheticmaterial such as silastic or other plastic, and may have serrations thatgrab on to the obturator fascia as the arms are pulled through thetissue.

In another embodiment, the arms of the sling include sutures. There maybe several sets of sutures on each side, in order to prevent thesub-rectal portion of the sling from rolling up underneath theanorectum.

In another embodiment, the arms of the sling may be attached to pelvicbone, such as the inferior-medial portion of the ischiopubic rami, orthe inferior portion of the pubis, with bone anchors, suture material,or other fixation devices.

In another embodiment, the material under and/or lateral to theano-rectum includes a synthetic material, such as silastic or otherplastic material, that may be flexible, to conform to the shape of thebowel.

In another embodiment, a number of synthetic or natural elements areattached to the mesh in a direction transverse to the length of thesling, such as perpendicular or substantially perpendicular to thelength of the sling. The elements may be semi-rigid and may be sopositioned in the mesh as to be located under or lateral to the bowelwhen the mesh is deployed, for the purpose of keeping the mesh fromrolling up underneath the anorectum. For example, the graft may have astiff or flexible bar incorporated into the graft, located on eitherside of the rectum, to prevent rolling of the graft material.

In another embodiment, the sling may have additional straps attached tothe subrectal portion that penetrate posteriorly, such as on either sideof the coccyx, that may pass through the subcutaneous tissue and holdthe graft in position, to prevent rolling of the subrectal mesh.

In another embodiment, the synthetic material may be elastic, which maypermit stretching of the sling with abdominal straining, such as occurswith voluntary defecation.

In another technique, the sling may be passed through the levator animuscle, rather than behind the muscles.

In another embodiment, the system may include a device used to evaluatethe anorectal angle, for pre-operative diagnosis, intra-operativeadjustment, and/or post-operative evaluation. The device is sufficientlyflexible that it can be flexed to conform to the anorectal angle. Theamount of flexion may be measured, thereby establishing the shape of theano-rectal angle. In one embodiment, the device may be inserted into therectum and has a flexible joint which is placed at the junction betweenthe anus and rectum. The device may then measure the angle createdbetween the rectal and anal portions, and this angle may be displayedvisually on the device, in one of a number of manners, including a dialor a digital display. The angle may also be communicated to an externaldisplay for convenience. The device may include a rotation- orposition-sensitive transducer. This ano-rectal angle measurement devicemay be adapted so that is fits over the examiner's gloved finger with aportion that fits over or on the examiner's distal finger, and anotherportion that fits over or on the proximal finger. In this manner, whenthe examiner bends his or her finger to determine the ano-rectal angle,the measured angle is recorded visually on a display.

Various portions of the device may be coated, impregnated, or formedwith one or more drugs to be eluted to an adjacent tissue. Variousportions of the device may be formed of biodegradable or bioabsorbablematerial.

FIG. 1 shows the anatomy of the bony pelvis, with the pubic symphysis(6), the ischiopubic ramus (2), the ischial tuberosity (9), the coccyx(4), and the obturator foramen (I). It also demonstrates therelationship of the levator ani muscles (and, in particular, thepuborectalis (8)) to the urethra (5), vagina (7), and rectum (3).

FIG. 2 demonstrates the placement of a needle (11) and attached handle(10) from the medial thigh incision (12), through the obturatormembrane, into the ischiorectal fossa, and the needle tip (14) emergingthrough the vertical incision (13) between the anus and the coccyx.

FIGS. 3-4 depict steps in one exemplary placement method. In FIG. 3, theneedle (11) with the attached handle (10) has been placed through thethigh incision and through the obturator foramen, through theischio-rectal fossa and out through the incision (13) between the anusand the coccyx. A suture loop (33) attached to the sling (16) is graspedby the needle tip (14) in order to transfer the sling to the thighincision. FIG. 4 demonstrates the second pass of the needle on thecontralateral side with the handle (10) and needle (11) in place. Thetip (14) is grasping the suture loop (33) in order to pull the other armof the sling up through to the thigh incision. This allows the centralportion of the sling (20) to rest under the ano-rectal area.

FIGS. 5-6 depict steps in another exemplary placement method. In FIG. 5,the needle (11) with attached handle (10) has been placed from thepost-anal vertical incision (13) up through the ischiorectal fossa,through the obturator foramen, and out through the thigh incision, andhas transferred a suture attached to the sling (18) to the thigh region.This allows the sling to be brought through the tissues up to the regionof the thigh. FIG. 6 shows the right side of the sling in place and theneedle (11) with attached handle (10) transferring a suture attached tothe left side of the sling arm (16) up through the left side. The sutureis being held by the needle tip (14).

FIG. 7 demonstrates a final position of the synthetic mesh (16) underthe anus and/or rectum, with the incision between the anus and thecoccyx (17), and up through the medial portion of the obturator membrane(15).

FIG. 8 demonstrates the use of two synthetic mesh straps placed throughthe obturator membrane, the first more distal and placed near thesuperior-medial aspect of the obturator foramen (18), and the secondplaced near the inferior portion of the obturator foramen (19), andattached to a central element (20).

FIG. 9 shows a lateral orientation of the pelvis with the pubicsymphysis (21), the bladder (22), the uterus (25), and the ischiorectalfossa (24) with two synthetic straps on each side, the first more distal(18) and the other more proximal (19), and a sub-rectal element (23)that includes a fluid or gas filled reservoir.

FIG. 10 shows a lateral orientation of the pelvis with the sling inplace, with an extension (26) of the sub-rectal element attached to thecoccyx with the use of sutures, bone anchor, or other method of affixingthe synthetic material to the coccyx.

FIGS. 11-13 demonstrate the use of a needle (27) introducer placed fromthe medial thigh to the incision under of the rectum. Once through thetissue, the jaw opens in the middle, which reveals a grasping instrument(28) that can hold on to a suture (29) affixed to the mesh (30) with orwithout a plastic sheath (31). The sling material is then broughtthrough the tissue, with or without a plastic outer tubing (26) throughwhich the grasper had been placed during the needle insertion.

FIGS. 14-16 demonstrate a needle (32) that, after insertion through thetissue, can be advanced beyond the outer sheath, with or without aspring-mechanism to deploy the needle. This reveals a notch, on whichthe suture loop (previously attached to the mesh), can be placed (33),and the sling (30) is then brought up through the tissues to the medialthigh

FIGS. 17-19 demonstrate a needle (34) that, after insertion through thetissue, may be separated from the shaft of the needle by unscrewing theneedle tip. The sling would have a male-connector screw (36) thatattaches to the straight needle shaft (35) and then the needle iswithdrawn, which draws the mesh up through the tissue.

FIG. 20 demonstrates a sling that has narrow arms (16) and a wider areawhich would sit under the rectum (37) and distribute forces over a widearea. FIG. 21 illustrates a sling central portion (arms not shown) thathas a curved shaped, specifically, a saddle shape. The saddle shape mayfacilitate making good contact with the anatomy to be supported. Itspositioning is illustrated in FIGS. 40-41. One curve of the saddleallows the sling to arc between the obturator regions, while the othercurve can complement the anorectal angle. FIG. 22 demonstrates anelongated central sling (20) with four attached arms, two of which arepassed from the medial superior portion of the obturator membrane (18),and the other two which are passed through the inferior portion of theobturator membrane (19).

FIG. 23 demonstrates a superior view of a mesh that has a fluid-filledsac on the superior side of the graft material.

FIG. 24 shows another embodiment of a sling having a central portionwith an inflatable sac. Connector tubing is attached to the fluid-filledsac and can be placed under the buttocks or other location within thereach of the tubing, and has a port at the end that can be used forfilling or reducing the amount of fluid is contained within the sac.

FIG. 25 demonstrates an inferior view of the central portion (20), whichshows a port from the fluid-filled sac coming out through a hole at thebottom of the graft (40). This port may be accessed subcutaneously inorder to either add more fluid or remove fluid.

FIGS. 26-29 exhibit an exemplary use of a loop stylet. Stylet (41) maybe advanced through tube (42). A length of sling material (43) may bethreaded through the loop so that the material catches in the loop. Thestylet may then be withdrawn back through the tube to bring the end ofthe sling material to the desired position.

FIGS. 30-31 show an exemplary use of a hook stylet (44). A piece ofsling material (45) may be stabbed onto a sharp tip of the hook. Thehook may then be withdrawn through a tube to bring the end of the slingmaterial to the desired location.

FIG. 32 shows a hybrid sling, comprised of, for instance, synthetic mesharms attached to a central natural material placed under and/or lateralto the ano-rectum.

FIG. 33 shows the sling with additional straps of material that areattached to the subrectal portion of the device, and are secured inplace by passage into subcutaneous tissue, in order to prevent rollingof the sling. The straps may be directed posteriorly, on either side ofthe coccyx, in order to keep the subrectal portion flat.

FIG. 34 demonstrates a sling made of a synthetic material such assilastic or other plastic with serrations on each arm that maintain thesling in position after adjustment by the surgeon FIGS. 35-37 showembodiments of slings that include rigid or semi-rigid elements (46).The elements may be attached to the sling in order to keep the slingfrom rolling under the ano-rectal portion.

FIG. 38 shows the use of bone anchors to hold the sling into position,in this case to the inferior-medial portion of the ischiopubic rami.

FIG. 39 depicts a device attached to the examiner's finger used tomeasure the angle between the rectum (3) and anus. The vagina (7) restsanterior to the anus and rectum, and the coccyx (4) is located posteriorto the rectum. A proximal ring (54) is placed on the proximal phalanx(51) and the distal ring (55) is placed on the distal phalanx (50) andthese are connected by a joint (53). The angle made between the anus andrectum is measured and displayed on a visual scale (52).

In one exemplary embodiment, a method to treat anal incontinence and/ordefecatory dysfunction in a male or female may include:

placing an implant that passes under the anus and/or rectum and may passunder, over, or through the levator ani muscles; placing one of the endsof the implant through the obturator foramen and through an incisionmade in the medial thigh on the same side of the patient; and providingan elongate instrument that is used to transfer one end of the implantfrom the post-anal incision to a medial thigh incision, and thentransferring the other end of the implant from the post-anal incision tothe other medial thigh incision; or

providing an elongate instrument that is used to transfer one end of theimplant from a medial thigh incision to the post-anal incision, and thentransferring the other end of the implant from the other medial thighincision to the post-anal incision.

In another exemplary, a method of treating anal incontinence and/ordefecatory dysfunction in a male or female patient may include:

creating an incision between the anus and the coccyx (vertical orhorizontal);

creating an incision in the medial portion of each thigh;

providing an elongate instrument and an elongate implant for treatingthe condition;

passing one of the ends of the instrument between the post-analincision, through an obturator foramen on one side of the patient, andthe incision on the respective medial thigh;

associating the implant with the instrument;

using the instrument to pass the implant through the tissue between thepostanal incision and one thigh incision such that the implant extendsbetween the postanal incision, through the one obturator foramen, andone of the thigh incisions;

passing one of the ends of the same or another instrument between thepostanal incision, through the other obturator foramen, and the otherthigh incision; and

using the instrument to extend the implant between the post-analincision, through the other obturator foramen, to the other thighincision such that the implant then extends from one thigh incision tothe other thigh incision, through both obturator foramen and under thepatient's rectum and/or anus (below or above the level of the levatorani muscles).

Various embodiments disclosed herein can be combined with one another toprovide additional embodiments that include multiple features.

In another aspect of the present invention, the various slings andinsertion needles described above in reference to the treatment of analincontinence may be used in conjunction with a method for the treatmentof pelvic organ prolapse. Pelvic organ prolapse is a condition whereorgans, such as the uterus, the rectum, or the bladder, fall down orslip out of place within a person's body. It is commonly used inreference to organs protruding through a woman's vagina, but prolapsemay occur within men as well. In a normal woman, the pelvic floormuscles support most of the weight of the pelvic organs, such as thevagina, uterus, bladder, and rectum. Additionally, the various pelvicfascia and ligaments stabilize these structures in position. When thenormal anatomic relationships in the pelvis are disrupted, or ifinjuries occur, dysfunctions such as urinary incontinence, fecalincontinence, or prolapse of the pelvic organs, may occur. For example,if the levator ani muscle is damaged, the muscle may be unable toadequately support the weight of the pelvic organs. This will result ina disproportionate amount of the pelvic organ weight being placed ontothe pelvic ligaments, which are significantly weaker than the fibroustissue of the ligaments that connect bones. In particular, the pelvicligaments are more accurately described as thickening of the endopelvicfascia tissue, which is composed of collagen, smooth muscle, elastin,and fibrovascular bundles. These ligaments are not designed to carry theincreased load resulting from problems in the pelvic floor. As a result,these ligaments may eventually fail. The failure or damage to the pelvicfloor ligaments may cause, for example, the bladder, rectum, or uterusto prolapse through the vagina. Similarly, expansion of or damage to thelevator or rectal hiatus may result in the bladder, vagina, or rectumprolapsing through the hiatus.

FIG. 42 generally depicts one exemplary method for treating pelvic organprolapse according to the present invention. The method begins at step 1where a physician marks the location of four incisions on a patient'spelvic region. In particular, the physician marks two posteriorincisions 60A and 60B and two thigh incisions 62A and 62B. The posteriorincisions 60A and 60B may be located about 1.5 cm lateral and about 3 cmposterior to the mid-anus (midway between the anus and the coccyx). Thetwo thigh incisions 62A and 62B may be, for example, at the level of theurethra along the descending pubic ramus.

The method continues at step 2 where the physician may inject a localanesthetic along a track from each thigh incision to the correspondingpost-anal incision on the ipsilateral side, and between the twopost-anal incisions. Then, in step 3, the physician uses a scalpel tomake the two posterior incisions 60A and 60B, which may be approximately1.5 cm in length. Next, in step 4, a small curved Kelly clamp or similarinstrument is used to tunnel subcutaneously between the two posteriorincisions 60A and 60B to create a space between the incisions, posteriorto the anus. The physician may place a finger in the rectum to assist inguiding the clamp during the tunneling process. The method continues atstep 5 where the physician inserts the clamp into posterior incision 60Band through posterior incision 60A, grasping an end portion of a slingarm or a connector on the sling. Thereafter, the physician pulls thesling through both incisions 60A and 60B until the central portion ofthe sling lies beneath the ano-rectum.

Then, in step 6, the physician makes a small stab incision over a firstone of the thigh incision marks to create thigh incision 62A. Aninsertion needle (such as, for example, needle 11) is then insertedthrough thigh incision 62A in step 7 until it perforates the obturatormembrane. The needle is tracked around the ischiopubic ramus with thehandle portion of the needle generally parallel to the pelvic floor. Thephysician may use a finger to track the path of the needle down next tothe vagina. Next, in step 8, the physician moves his finger to posteriorincision 60A to track the needle out of the incision. The procedurecontinues at step 9 where the physician attaches the needle to theconnector on the end of the sling arm protruding outward from posteriorincision 60A and withdraws the needle back through the tissue and outthrough thigh incision 62A, pulling the sling arm to the desiredlocation.

Next, in step 10, the physician makes a small stab incision over thesecond thigh incision mark to create thigh incision 62B. The insertionneedle is then inserted through thigh incision 62B in step 11 until itperforates the obturator membrane. The needle is again tracked aroundthe ischiopubic ramus with the handle portion of the needle generallyparallel to the pelvic floor. Thereafter, in step 12, the physicianmoves his finger to posterior incision 60B to track the needle out ofthe incision. The procedure continues at step 13 where the physicianattaches the needle to the connector on the end of the sling armprotruding outward from posterior incision 60B and withdraws the needleback through the tissue and out through thigh incision 62B, pulling thesling arm to the desired location. Once the physician has grasped andpulled both of the sling arms through the corresponding thigh incisions62A and 62B, posterior incisions 60A and 60B may then be irrigated withan antibiotic solution and sutured in step 14.

Next, with a finger inserted into the rectum, the physician adjusts thesling arms in step 15 by grasping the excess portions of the armsprotruding from thigh incisions 62A and 62B and pulling upward on botharms until gentle tension is palpable through the rectum. Then, keepinga finger in the rectum, the physician cuts the sling arms (as well asthe sheath, if present) from the insertion needles and the sheaths areremoved, leaving the sling mesh in place. The sling arms are then cutclose to the patient's skin such that any excess portions of the slingarms protruding outward from the thigh incisions 62A and 62B areremoved. The thigh incisions 62A and 62B are then irrigated with anantibiotic solution and subsequently sutured in step 16, therebycompleting the pelvic floor treatment procedure. The sling, which may beconstructed as a mesh formed from many materials such as, for example,polypropylene, adheres to internal body tissue without the need foradditional sutures or attachment means.

One skilled in the art will appreciate that the procedure describedabove is merely one example of a method for treating pelvic organprolapse according to the present invention. Thus, the steps describedabove may be modified or re-ordered without departing from the intendedscope of the present invention. In addition, insertion needles andslings other than those shown and described above in reference to FIGS.2-41 may be used along with the method of the present invention fortreating pelvic organ prolapse. Furthermore, although the method wasdescribed with reference to the treatment of pelvic organ prolapse in afemale patient, those skilled in the art will appreciate that a similarmethod may be used to treat pelvic organ prolapse in a male patient aswell.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

1. A sling comprising a central portion having a hyperbolic paraboloidshape structured to be positioned posteriorly to the rectum and/or anusof a subject and attached to at least two arms extending therefrom. 2.The sling of claim 1, wherein the central portion comprises aninflatable sac.
 3. The sling of claim 2, wherein at least one arm isformed of mesh.
 4. The sling of claim 2, wherein at least one arm isformed of tension-free vaginal tape.
 5. The sling of claim 2, wherein atleast one arm terminates with a filament.
 6. The sling of claim 5,wherein the filament comprises a suture.
 7. A sling comprising: acentral portion having an inflatable sac attached thereto, the centralportion being preformed with a hyperbolic paraboloid shape structured tobe positioned posteriorly to the rectum and/or anus of a subject; and atleast two arms extending from the central portion, the arms formed ofmesh or tension-free vaginal tape.